Hematologic Malignancies
Conditions
Keywords
Cancer, Hematologic Malignancies, venetoclax, ethinyl estradiol, relapsed or refractory non-Hodgkin's lymphoma, non-Hodgkin's lymphoma
Brief summary
A study to assess the effect of multiple doses of venetoclax on the pharmacokinetics of ethinyl estradiol and levonorgestrel in female participants with different hematological malignancies. Upon completion of this study, participants receiving clinical benefit in the opinion of the investigator and without any clinically significant evidence of disease progression with no access to venetoclax (not approved for the treated indication) may continue receiving venetoclax at the discretion of the investigator in a separate extension study.
Interventions
DRUGVenetoclax
tablet; oral
tablet; oral
Sponsors
AbbVie
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Participant must have relapsed or refractory non-Hodgkin's lymphoma (NHL). * Participant must have histologically documented diagnosis of one of the following NHL subtypes: diffuse large B-cell lymphoma (DLBCL), follicular lymphoma (FL), lymphoplasmacytic lymphoma (LPL), mantle cell lymphoma (MCL), marginal zone lymphoma (MZL), T-cell prolymphocytic lymphoma (T-PLL), Waldenström's macroglobulinemia (WM) * Has an Eastern Cooperative Oncology Group (ECOG) performance score of less than or equal to two. * Must have adequate bone marrow, coagulation, renal and hepatic function as described in the protocol. * A female of non-childbearing potential as described in the protocol.
Exclusion criteria
* History of currently active, clinically significant cardiovascular disease. * If the participant has had prior stem cell transplantation, it must have been more than 100 days prior to start of study drug, with no graft versus host disease, and no immunosuppression therapy. * evidence of transformation of the lymphoma immediately prior to study entry. * Evidence of central nervous system involvement by lymphoma.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Tmax of Venetoclax | Up to approximately 59 days after initial study drug dose | Time to maximum plasma concentration (Tmax) of Venetoclax. |
| Tmax of (ethinyl estradiol) EE/Levonorgestrel | Up to approximately 59 days after initial study drug dose | Time to maximum plasma concentration (Tmax) of EE/Levonorgestrel |
| Cmax of Venetoclax | Up to approximately 59 days after initial study drug dose | Maximum plasma concentration (Cmax) of Venetoclax |
| Cmax of EE/Levonorgestrel | Up to approximately 59 days after initial study drug dose | Maximum plasma concentration (Cmax) of EE/Levonorgestrel |
| t1/2 of Venetoclax | Up to approximately 59 days after initial study drug dose | Terminal phase elimination half-life (t1/2) of Venetoclax. |
| t1/2 of EE/Levonorgestrel | Up to approximately 59 days after initial study drug dose | Terminal phase elimination half-life (t1/2) of EE/Levonorgestrel |
| AUCt of Venetoclax | Up to approximately 59 days after initial study drug dose | Area under the plasma concentration-time curve (AUC) from time 0 to time of the last measurable concentration (AUCt) of Venetoclax |
| AUCt of EE/Levonorgestrel | Up to approximately 59 days after initial study drug dose | Area under the plasma concentration-time curve (AUC) from time 0 to time of the last measurable concentration (AUCt) of EE/Levonorgestrel |
| AUCinf of EE/Levonorgestrel | Up to approximately 59 days after initial study drug dose | AUC from time 0 extrapolated to infinite time (AUCinf) of EE/Levonorgestrel. |
Countries
Australia, United States
Contacts
Primary ContactABBVIE CALL CENTER
Outcome results
None listed